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The goal of this clinical trial is to learn if Golden Rice Cookies with Piper crocatum can help improve fasting blood sugar and quality of life in people living with HIV who have hyperglycemia (GRC-HIV). It will also learn about the safety and acceptability of this dietary intervention.
The main questions it aims to answer are:
Does Golden Rice Cookies with Piper crocatum lower fasting blood sugar levels in PLHIV with hyperglycemia? Does Golden Rice Cookies with Piper crocatum improve quality of life in PLHIV with hyperglycemia? Researchers will compare Golden Rice Cookies with Piper crocatum to control cookies (iso-caloric cookies without Golden Rice and Piper crocatum) to see if Golden Rice Cookies are effective.
Participants will:
Consume either Golden Rice Cookies with Piper crocatum or control cookies every day for 28 days Visit the clinic at baseline and follow-up for checkups, laboratory tests, and questionnaires Record their daily cookie consumption and any symptoms or side effects in a diary
People living with HIV (PLHIV) are at higher risk of developing hyperglycemia due to long-term antiretroviral therapy (ART), metabolic complications, and lifestyle factors. Hyperglycemia not only worsens the prognosis of HIV but also negatively affects quality of life. Dietary interventions using functional foods may provide a safe and acceptable strategy to address this issue.
Golden Rice is biofortified with β-carotene, which has been associated with improved insulin sensitivity and reduced glycemic response. Piper crocatum (red betel leaf) contains polyphenols, flavonoids, and tannins with antidiabetic, antioxidant, and anti-inflammatory properties. Combining Golden Rice and Piper crocatum in a practical cookie form offers a potentially effective and acceptable intervention for PLHIV with hyperglycemia.
This trial is designed to evaluate whether daily consumption of Golden Rice Cookies enriched with Piper crocatum can improve fasting plasma glucose and health-related quality of life in PLHIV with hyperglycemia compared to iso-caloric control cookies. The findings may contribute to evidence-based dietary strategies to improve metabolic outcomes and well-being in PLHIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golden Rice Cookies With Piper crocatum | Experimental | Participants in this group will consume Golden Rice cookies enriched with Piper crocatum. Each participant will receive 20 g twice daily (40 g/day total) for 28 days. The cookies are designed to be iso-caloric with the control cookies and packaged identically to maintain participant blinding. |
|
| so-Caloric Cookies Without Golden Rice and Piper crocatum | Placebo Comparator | Participants in this group will consume placebo cookies made from standard flour without Golden Rice and without Piper crocatum. Each participant will receive 20 g twice daily (40 g/day total) for 28 days. The cookies are calorie-matched and designed to resemble the intervention cookies in appearance but do not contain the active ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golden Rice Cookies With Piper crocatum | Dietary Supplement | Golden Rice cookies enriched with Piper crocatum were formulated as a functional food containing β-carotene and bioactive compounds (polyphenols, flavonoids, tannins). Participants in the experimental arm consume 20 g twice daily (40 g/day total) for 28 days. The cookies are iso-caloric with control cookies but differ by inclusion of Golden Rice and Piper crocatum. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose | Change in fasting plasma glucose level from baseline to Day 28, measured using enzymatic method after 8-10 hours of fasting. Measurement scale:
| Baseline and 28 days |
| Change in Health-Related Quality of Life | Change in quality of life score assessed using WHOQOL-HIV BREF questionnaire from baseline to Day 28. Measurement results:
| Baseline and 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puskesmas Ujung Pandang Baru | Makassar | South Sulawesi | 92173 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19369372 | Result | Tang G, Qin J, Dolnikowski GG, Russell RM, Grusak MA. Golden Rice is an effective source of vitamin A. Am J Clin Nutr. 2009 Jun;89(6):1776-83. doi: 10.3945/ajcn.2008.27119. Epub 2009 Apr 15. | |
| 34867030 | Result | Setyawati A, Wahyuningsih MSH, Nugrahaningsih DAA, Effendy C, Fneish F, Fortwengel G. Piper crocatum Ruiz & Pav. ameliorates wound healing through p53, E-cadherin and SOD1 pathways on wounded hyperglycemia fibroblasts. Saudi J Biol Sci. 2021 Dec;28(12):7257-7268. doi: 10.1016/j.sjbs.2021.08.039. Epub 2021 Aug 19. |
| Label | URL |
|---|---|
| Official website of the Faculty of Nursing, Universitas Hasanuddin provides information on academic programs (including Master of Nursing ), research activities, organizational structure, and institutional collaborations. | View source |
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Individual participant data will not be shared because of confidentiality and privacy considerations for people living with HIV, as well as institutional data protection policies.
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Participants will be randomly assigned in parallel to one of two groups: the intervention group receiving Golden Rice Cookies with Piper crocatum or the control group receiving placebo. Both groups will consume their assigned cookies daily for 28 days
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Only participants are blinded to group assignment. The intervention and control cookies are made to appear similar in packaging and portion, so participants do not know whether they are receiving Golden Rice Cookies with Piper crocatum or control cookies.
|
| Iso-Caloric Control Cookies (Placebo) | Other | Iso-caloric cookies made from standard flour without Golden Rice and without Piper crocatum. Participants in the control arm consume 20 g twice daily (40 g/day total) for 28 days. The cookies are designed to match the intervention cookies in calories and appearance but do not contain the active ingredients. |
|
| 31789685 | Result | Zuniga JA, Jang DE, Walker G, Ohueri CW, A Garcia A. Differences in Health-Related Quality of Life Predictors in People Living With HIV With and Without Diabetes. J Assoc Nurses AIDS Care. 2020 Sep-Oct;31(5):544-552. doi: 10.1097/JNC.0000000000000138. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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